Balkinization: Big Pharma: the Unseemly First Amendment Champion, Part One"
by Jane Bambauer (University of Arizona Law School)
The pharmaceutical industry is enjoying the sort of influence over First Amendment jurisprudence once reserved for the likes of Hustler Magazine. In Sorrell v. IMS, the Supreme Court protected the transfer and use of prescription data for pharmaceutical detailing (that is, the in-person sales pitches that pharmaceutical reps make to doctors.)
A more significant free speech victory for Big Pharma was delivered by the Second Circuit in United States v. Caronia, which overturned the conviction of a pharmaceutical detailer for off-label marketing of a drug. Public health experts and constitutional law scholars are intensely critical of these developments, arguing that they are perversions of the First Amendment to favor large corporations at the expense of consumer protection. For reasons I sketch here, their reactions overstate the conflict between Big Pharma and public health and underestimate the First Amendment interests at stake."
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Placebo-controlled double-blind experiments might be an appropriate standard for a scientific journal, but those journals have the luxury of avoiding the constant stream of hard decisions that every doctor and consumer must make. At a critical point of deliberation, bad science on a drug’s risks and benefitscould be better than no science at all.
Moreover, the agencies also risk training the public to think that scientific conventions are tantamount to “truth” which is, ironically, antithetical to the scientific process. Science is messy, tentative, and error-prone. We can get a sense of this just by considering the (arbitrarily chosen) 5% standard for statistical significance. A result that is statistically significant at the 5% level deserves a lot of confidence when it is viewed alone. However, as soon as we pull together fifteen statistically significant findings, the chance that at least one of the findings is actually random noise exceeds 50%. If we pull together a hundred studies, which is often what our body of public health knowledge consists of, the chance that every statement is true falls to under 1%. Add to this the fact that most public health research cannot be replicated and we get a humbling picture. Even when evidence-based claims live up to the current standards of scientific rigor, we are fumbling in the dark. (I don’t mean to be too pessimistic here; observational studies and controlled experiments are the only thing that takes us from wrong to veryslightly less wrong, and that's a good thing.)
The FDA’s regulations rely on an assumption that less-than-rigorous scientific statements in favor of a drug’s adoption on balance not only alter doctor behavior, but also lead to patient harm. This assumption may be correct, but at present it lacks a basis in evidence. Profits and good advice are not always at odds. When they pull in the same direction, skepticism and regulation can get in the way of health improvements. For example, there are some drugs, such as tPA for the treatment of stroke, that are so effective that the lag among ER doctors to use it is simply tragic. The public health community has not been able to show that pharmaceutical detailing causes more harm than good, which is why the health-related justifications in Sorrell were unconvincing. In the absence of evidence that the free exchange of information causes harm, the FDA’s approach is in trouble. It flies in the teeth of the Brandeisian assumption that bad information is best countered by more information rather than censorship.
I suspect that, in the wake of Caronia, Sorrell, and other cases, courts will apply intermediate scrutiny to any restrictions on commercial speech that is not provably false. Courts will not defer to agencies on the definition of misleading, so if an agency regulates speech that is technically true but arguably misleading and distortive, it will have to come to court with evidence of the potential for both misinterpretation and consequent harm.
This shift will not be a welcome one to critics who think that the commercial speech doctrine waswrongheaded from the start. But these critics tend to undervalue consumer and listener interests in advertising, and to overlook other, better, alternatives for promoting good research. (To be continued in Part Two.)
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by Jane Bambauer (University of Arizona Law School)
The pharmaceutical industry is enjoying the sort of influence over First Amendment jurisprudence once reserved for the likes of Hustler Magazine. In Sorrell v. IMS, the Supreme Court protected the transfer and use of prescription data for pharmaceutical detailing (that is, the in-person sales pitches that pharmaceutical reps make to doctors.)
A more significant free speech victory for Big Pharma was delivered by the Second Circuit in United States v. Caronia, which overturned the conviction of a pharmaceutical detailer for off-label marketing of a drug. Public health experts and constitutional law scholars are intensely critical of these developments, arguing that they are perversions of the First Amendment to favor large corporations at the expense of consumer protection. For reasons I sketch here, their reactions overstate the conflict between Big Pharma and public health and underestimate the First Amendment interests at stake."
*******
Placebo-controlled double-blind experiments might be an appropriate standard for a scientific journal, but those journals have the luxury of avoiding the constant stream of hard decisions that every doctor and consumer must make. At a critical point of deliberation, bad science on a drug’s risks and benefitscould be better than no science at all.
Moreover, the agencies also risk training the public to think that scientific conventions are tantamount to “truth” which is, ironically, antithetical to the scientific process. Science is messy, tentative, and error-prone. We can get a sense of this just by considering the (arbitrarily chosen) 5% standard for statistical significance. A result that is statistically significant at the 5% level deserves a lot of confidence when it is viewed alone. However, as soon as we pull together fifteen statistically significant findings, the chance that at least one of the findings is actually random noise exceeds 50%. If we pull together a hundred studies, which is often what our body of public health knowledge consists of, the chance that every statement is true falls to under 1%. Add to this the fact that most public health research cannot be replicated and we get a humbling picture. Even when evidence-based claims live up to the current standards of scientific rigor, we are fumbling in the dark. (I don’t mean to be too pessimistic here; observational studies and controlled experiments are the only thing that takes us from wrong to veryslightly less wrong, and that's a good thing.)
The FDA’s regulations rely on an assumption that less-than-rigorous scientific statements in favor of a drug’s adoption on balance not only alter doctor behavior, but also lead to patient harm. This assumption may be correct, but at present it lacks a basis in evidence. Profits and good advice are not always at odds. When they pull in the same direction, skepticism and regulation can get in the way of health improvements. For example, there are some drugs, such as tPA for the treatment of stroke, that are so effective that the lag among ER doctors to use it is simply tragic. The public health community has not been able to show that pharmaceutical detailing causes more harm than good, which is why the health-related justifications in Sorrell were unconvincing. In the absence of evidence that the free exchange of information causes harm, the FDA’s approach is in trouble. It flies in the teeth of the Brandeisian assumption that bad information is best countered by more information rather than censorship.
I suspect that, in the wake of Caronia, Sorrell, and other cases, courts will apply intermediate scrutiny to any restrictions on commercial speech that is not provably false. Courts will not defer to agencies on the definition of misleading, so if an agency regulates speech that is technically true but arguably misleading and distortive, it will have to come to court with evidence of the potential for both misinterpretation and consequent harm.
This shift will not be a welcome one to critics who think that the commercial speech doctrine waswrongheaded from the start. But these critics tend to undervalue consumer and listener interests in advertising, and to overlook other, better, alternatives for promoting good research. (To be continued in Part Two.)
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